BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 6148828 · Received December 6, 2016

    Report

    Report Number
    3004753838-2016-71678
    Event Type
    Malfunction
    Date Received
    December 6, 2016
    Date of Event
    November 15, 2016
    Report Date
    November 15, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2016, THAT ON (B)(6) 2016, THERE WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER. THE SENSOR WAS INSERTED AT THE LEG ON (B)(6) 2016. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE REPORTED INACCURACY COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. LABELING INDICATES: SENSOR PLACEMENT AND INSERTION IS NOT APPROVED FOR SITES OTHER THAN THE BELLY (ABDOMEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799512 NI CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 ASKU 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR